Study of SGR-1505 in Mature B-Cell Neoplasms

Schrödinger, Inc.

Status and phase: Enrolling; Phase 1

Conditions: DLBCL Germinal Center B-Cell Type; Waldenstrom Macroglobulinemia; Nodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; High-grade B-cell Lymphoma; Lymphoplasmacytic Lymphoma; Non Hodgkin Lymphoma; T-Cell/Histiocyte Rich Lymphoma; MALT Lymphoma; Follicular Lymphoma; Primary Cutaneous Follicle Center Lymphoma; Primary Cutaneous Diffuse Large B-Cell Lymphoma; Burkitt Lymphoma; ALK-Positive Large B-Cell Lymphoma; HHV8-Positive DLBCL, Nos; EBV-Positive DLBCL, Nos; Pediatric-Type Follicular Lymphoma; Mantle Cell Lymphoma; DLBCL; Duodenal-Type Follicular Lymphoma; Primary Mediastinal Large B Cell Lymphoma; Mature B-Cell Neoplasm; Plasmablastic Lymphoma; Primary Effusion Lymphoma; Chronic Lymphocytic Leukemia; IRF4 Gene Rearrangement

Treatments: Drug: SGR-1505

Study type: Interventional

Funder types: Industry

Identifiers

NCT05544019

SGR-1505-101

Details and patient eligibility

About

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.

Full description

This is a study of SGR-1505, an oral inhibitor of MALT1, in subjects with relapsed/refractory (R/R) B-cell lymphomas to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505. Exploratory cohorts will evaluate additional PK, PD, preliminary anti-tumor activity, and safety to establish the SGR-1505 RD. A planned amendment will evaluate SGR-1505 in combination with other anti-cancer agents, such as BTK and BCL-2 inhibitors, in patients with specific B-cell malignancies.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
• Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks.

Exclusion criteria

• The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
• Subject has previous invasive malignancy in the last 2 years.
• Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
• Subject has symptomatic or active CNS involvement of disease.
• Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Dose Escalation

Experimental group

Description:

Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation.

Treatment:

Drug: SGR-1505